Breathing mask arrangement as well as an application device and a forehead support device for same

ABSTRACT

A breathing mask arrangement includes an arch body, a sealing lip means for bearing against the surface of the face of a mask user, a respiratory gas conduit means for feeding respiratory gas to a mask internal space which is defined by the arch body and which is in communication with the nose and/or mouth opening of the user of the mask, and an application structure for application of the sealing lip means jointly with the arch body, wherein the application structure has a carrier portion on which a respiratory gas conduit member is releasably coupled.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/829,864, filed Aug. 19, 2015, now allowed, which is a continuation ofU.S. application Ser. No. 13/923,671, filed Jun. 21, 2013, now U.S. Pat.No. 9,144,656, which is a continuation of U.S. application Ser. No.13/067,282, filed May 20, 2011, now U.S. Pat. No. 8,479,738, which is acontinuation of U.S. application Ser. No. 11/987,164, filed Nov. 28,2007, now U.S. Pat. No. 7,992,559, which is a continuation of U.S.application Ser. No. 10/493,424, filed Apr. 22, 2004, now U.S. Pat. No.7,320,323, which is the US National Phase of International ApplicationNo. PCT/EP02/011798, filed Oct. 22, 2002, which designated the US.PCT/EP02/011798 claims priority to DE Application No. 101 51 984.2,filed Oct. 22, 2001, DE Application No. 102 01 682.8, filed Jan. 17,2002, and International Application No. PCT/EP02/02877, filed Mar. 14,2002. Each of these applications are incorporated herein by reference intheir entirety.

FIELD OF THE INVENTION

The invention concerns a breathing mask arrangement as can be used forexample in the context of CPAP-therapy for treating sleep-relatedbreathing disorders. The invention further concerns a forehead supportdevice for a breathing mask arrangement.

BACKGROUND OF THE INVENTION

In the context of what is referred to as CPAP-therapy a patient can besupplied by way of a breathing mask arrangement with a breathable gas,in particular ambient air at a pressure level which is above the ambientpressure level. The respiratory gas which is under pressure makes itpossible to provide for pneumatic splinting of the upper respiratorytracts and thus to obviate any obstructions. In the course ofimplementing pressure respiration or CPAP-therapy the breathing maskarrangements which are required to supply the respiratory gas areusually worn by the patient over the entire sleep or rest phase of thepatient. The breathing mask arrangement is usually supported by way of asealing lip zone in the region around the nose of the person using themask and by way of a forehead support device in the forehead region ofthe mask user. The holding forces required to apply the breathing maskarrangement can be afforded by a fixing device which for example has aheadband which is passed around the back of the head of the mask user.Under some circumstances, in the region in which the sealing lip deviceis applied and in the contact region of the forehead support device,surface pressures can occur, which result in the level of comfortinvolved in wearing the breathing mask arrangement being seriouslyadversely affected. In dependence on the individual architecture of theface of the person wearing the mask, considerable mask-pressing forcesare in part required in order to achieve the desired sealing integrity.In that situation, in the region of the zones where the breathing maskbears against the face of the patient, unacceptably clearly visiblepressure points may also be caused in the forehead region.

OBJECT OF THE INVENTION

The object of the invention is to provide a structure by which abreathing mask arrangement can be fixed in a correct applicationposition and a high level of wearing comfort can be achieved. Attainmentof the object in accordance with the invention

In accordance with the invention that object is attained by a breathingmask arrangement comprising an arch body, a sealing lip means forbearing against the surface of the face of a mask user, a respiratorygas conduit means for feeding respiratory gas to a mask internal spacewhich is defined by the arch body and which is in communication with thenose and/or mouth opening of the user of the mask, and an applicationstructure for application of the sealing lip means jointly with the archbody, wherein the application structure has a carrier portion on which arespiratory gas conduit member is mounted.

In that way it is advantageously possible to provide a breathing maskarrangement which is of a robust structure and which can be cleaned inan advantageous manner and which is distinguished by a high level ofsealing integrity.

In accordance with a particularly preferred embodiment of the inventionthe respiratory gas conduit member is in the form of a tube connection.Such a tube connection is preferably made from dishwasher-resistantplastic material so that the respiratory gas conduit member can becleaned at comparatively high temperatures and in the processsterilised. The tube connection is preferably of such a configurationthat its inside diameter is in the range of 12 to 34 mm. The tubeconnection can be of a substantially circular or preferably polygonalcross-section. The tube connection can be in the form of a conduit bendwhich provides for a slight change in direction of the flow ofrespiratory gas through an angle in the range of from 0 to 45°.

The conduit member which in particular is in the form of a tubeconnection is preferably releasably mountable to the carrier portion. Alatching device is preferably provided for coupling the respiratory gasconduit member to the carrier portion. In accordance with a particularaspect of the present invention that latching device is advantageouslyin the form of a bayonet or rotational latching device.

The application structure of the breathing mask arrangementadvantageously includes a frame portion which can be releasably coupledto the sealing lip means and/or to the arch body. Preferably the frameportion is designed in such a way that it embraces the arch body in aring or loop configuration. The carrier portion is advantageously madefrom a plastic material and is provided with holding members, by way ofwhich the carrier portion can be coupled for example to a lower web bandarrangement of a headband. Advantageously those holding members are inthe form of holding loops or clips, through which an end portion of theabove-mentioned lower web band arrangement can be passed. The holdingloops are preferably formed integrally with the carrier portion. Theinternal peripheral wall of a through opening formed by the holdingloops is preferably of a configuration which, in regard to the mouldingtool, permits removal of the holding loops from the mould withoutinvolving the use of a sliding pusher member.

The carrier portion provided for fixing the respiration gas conduitmember is advantageously formed integrally with the frame portion. Inthat respect the carrier portion is advantageously designed in such away that it has an insert opening into which the respiratory gas conduitmember can be releasably inserted. The carrier portion is preferablyarranged in such a way that it extends substantially perpendicularly toa frame surface defined by the frame portion.

In the region of the insert opening, the carrier portion preferablyforms those coupling structures which can be brought into engagementwith the respiratory gas conduit member which is in the form of the tubeconnection.

The arch body preferably comprises a coupling portion, by way of whichthe arch body can be sealingly connected to the respiratory gas conduitmember. Preferably the arch body is produced from an elastomer materialand fitted with elastic expansion thereof on to a portion of the tubeconnection, which is passed through the insert opening and whichpenetrates to the sealing lip means. Preferably, a peripheral bead orridge is provided on that portion of the tube connection, which extendsas far as the sealing lip means, by means of which peripheral bead thearch body and the tube connection are reliably held in the joinedcondition.

In accordance with a particularly preferred embodiment of the inventionthe arch body is formed integrally with the sealing lip means. In thatway it is advantageously possible to avoid gaps or joints in thetransitional region between the sealing lip means and the arch body. Inaddition it is advantageously possible for the sealing lip means and thearch body to be inserted in the form of an integral elastomer componentinto the frame portion.

In accordance with a particularly preferred embodiment, particularlyreliable discharge of respiratory gas loaded with CO₂ to the ambientatmosphere is attained in that the arch body is provided with openingsthrough which the respiratory gas which is under pressure in theinternal region of the arch body can escape to the ambient atmosphere.The openings are preferably such that the cross-section thereof enlargesin the outlet direction. Those outlet openings are preferably arrangedin such a way that they are disposed as closely as possible to theregion which, in the position of application of the breathing maskarrangement, is adjacent to the nasal openings of a user of the mask.

In accordance with a particular aspect of the present invention theapplication structure includes a forehead support device for supportingthe breathing mask arrangement in the forehead region of the user of themask. The forehead support device is advantageously connected by way ofa pivot device to the frame portion which embraces the arch body. Byvirtue of that configuration it is advantageously possible for theposition of the forehead support device to be adapted to the individualfacial architecture or structure of the user of the mask. Preferably thepivot device includes an arcuate track guide means by which the foreheadsupport device can be variably positioned.

The respiratory gas conduit member which is preferably releasablycouplable to the carrier portion advantageously forms a docking portwhich for example can also form part of a rotary coupling structure. Itis possible to provide on the docking port further connecting devices,in particular small tube connections, by way of which for example apressure measuring hose can be coupled to the breathing mask arrangementor possibly an additional supply of oxygen can be effected.

The forehead support device is preferably made from a thermoplasticmaterial and provided with a forehead cushion means. The foreheadcushion means is preferably formed by elastomer elements which are of apad-like configuration and which can be coupled by way of a plugconnecting structure to the receiving portion of the forehead supportdevice, said receiving portion preferably being of a loop-likeconfiguration. In that case the forehead support device is preferablydesigned in such a way that the elastomer elements can be fitted to theforehead support device at different locations. Preferably the elastomerelements are also of such a configuration that, by virtue of the way inwhich they are fixed to the loop portion, it is also possible to achievedifferent positions of the contact regions of the elastomer elements onthe forehead of the user of the mask. The elastomer elements arepreferably made from a silicone rubber material and in the region oftheir contact surface are so shaped that transmission of the contactforces to the surface of the forehead of the user of the mask takesplace under a physiologically well compatible surface pressure. That canbe achieved in particular by the elastomer elements being provided, on arear side remote from their contact side, with an eccentrically arrangedsupport foot which permits a tilting movement of the contact portionwhich bears against the user of the mask.

Preferably, also provided on the loop portion are coupling portionswhich permit coupling of the forehead support device to an upperforehead band arrangement of a headband. Those coupling portions can bein the form of a band strip. It is also possible for the foreheadsupport device to be fixed for example by way of a hook-and-loopfastener to a preferably cushioned forehead band arrangement.

In accordance with a further aspect of the invention, another object ofthe invention is to prevent the occurrence of any pressure points in theforehead region in connection with the use of breathing masks.

In accordance with the invention that object is attained by a foreheadsupport device for a breathing mask comprising a contact element whichis provided in the application position for bearing against the foreheadregion of a user of the mask, wherein there is provided a holding devicefor holding the contact element movably.

By virtue thereof it is advantageously possible to ensure that abreathing mask arrangement is supported in the forehead region of apatient under a markedly reduced surface pressure against the tissue ofthe patient. The mobility of the contact element, which is provided inaccordance with the invention, means that it can automatically adapt tothe individual curvature of the forehead region of the user of the mask.In that way it is further advantageously possible for the contactelement to afford a large surface area, whereby it is advantageouslypossible to achieve a marked reduction in the surface pressure.

An embodiment of the forehead support device, which is preferred inaccordance with a particular aspect of the present invention, isafforded in that the holder is in the form of a pivotal holder. Thatpivotal holder advantageously permits a tilting movement of the contactelement about at least one axis substantially parallel to the usualcontact orientation. That pivotal holder can preferably be formed by apivot or hinge device which in accordance with a particularly preferredembodiment includes a ball joint. As an alternative thereto or also incombination with that configuration, it is possible for the pivot deviceto be formed by an elastomer structure. The range of movement of theholder of the contact element is preferably in the range of 10-30°. Itis possible to take sufficient account of all possible foreheadarchitectures within that angular range.

In accordance with a particular aspect of the present invention thecontact element is formed from an elastomer material, for example afully transparent or coloured silicone rubber material. Particularly inthis embodiment the contact element is of a preferably pad-like orplate-like configuration. In that case, the contact element ispreferably concavely inwardly curved in such a way that a defineddistribution in terms of surface pressure is afforded when the contactelement is applied to the surface of the forehead. In accordance with aparticularly preferred embodiment of the invention that surface pressureis so selected that, within a predetermined spacing from the edge of thecontact element, there is a substantially uniform surface pressure, withthe surface pressure gradually decreasing outwardly in the edge regionof the contact element.

In accordance with a particularly preferred embodiment of the inventionthe forehead support device includes a plurality of and preferably twomutually adjacently arranged contact elements. The contact elements arepreferably arranged in such a way that in the application position of abreathing mask arrangement, they are positioned above the left and righteyebrows of the user of the mask. The two contact elements arepreferably connected together by way of a flexible bridge or strapdevice. In that way, it is possible on the one hand to achieve a greaterincrease in the contact area while at the same time the possibility ofthe contact elements twisting relative to each other can be limited in adefined manner. Particularly in this embodiment the two contact elementsare preferably formed integrally with each other. The configuration ofthe contact elements in a plan view is not limited to substantiallycircular external contours. For example it is also possible to adoptelliptical or other polygonal external contours.

The pivot device for pivotably movably mounting the respective contactelement is preferably also formed integrally with the contact element. Adefined pivot character can be achieved by virtue of suitablegeometrical configuration of the pivot device.

The pivot device is preferably arranged in such a way that it isdisposed on or at least near the line of action of a force which extendsthrough a centre point in terms of surface pressure of the respectivecontact element. That still further promotes rendering the distributionof surface pressure uniform.

The contact elements are preferably profiled in such a way that thecontact element is prevented from being applied by suction to thesurface of the forehead of the patient. Suction of the forehead supportdevice on the surface of the forehead of the patient can further also beobviated by the contact element being provided with through bores oralso with passages, through which air can pass into an intermediateregion between the contact element and the forehead of the user of themask.

The ball joint structures advantageously provide for good adaptabilityto the horizontal and vertical configuration of the forehead of the userof the mask. The pivot device—in particular the ball joint means—canalso be designed to be lockable. The pivot device can also preferably betiltable in a particularly advantageous manner about given axes—inparticular about a horizontal axis. The curvature of the contact elementcan be so selected that different radii of curvature are afforded in thehorizontal and vertical directions. The radii of curvature arepreferably smaller than the usual radii of curvature of a forehead.

As an alternative to ball joint structures it is also possible to adoptcardanic suspension means, for example by means of a pivot pin. Theangle of pivotal movement of the pivot device is preferably limited to apredetermined abutment angle. The material properties of the contactelement are preferably so selected that it has a substantiallyanti-bacterial action and possibly acts to promote the healing ofwounds.

Advantageously, a cushion means, in particular a gel body cushion means,or also an air or liquid cushion means, can be provided in the region ofthe contact surface. In that case, by varying the amount of liquid, airor gel used, it is advantageously possible to adjust the position of thebreathing mask relative to the user.

Advantageously the mounting position of the contact element isadjustably variable. As an alternative thereto—or also in combinationwith this feature—it is also possible to provide a plurality of couplingoptions so that it is possible to achieve varying spacings on theforehead, by suitable selective coupling. It is possible to implementcoarse adjustment by for example two, preferably three or also morecoupling options, and to implement preferably stepless fine adjustmentwithin a limited fine adjustment range. It is possible to permit aplurality of permutation options, in which case the individual couplingpermutations result in respectively different settings in terms of thespacing relative to the forehead. It is also possible to provideclamping structures, by means of which stepless adjustment of thespacing relative to the forehead is possible. The coupling means can beso designed that a defined adhesive location is achieved, so that asetting which is individually steplessly adapted is durably maintainedby adhesive means.

In accordance with a particularly preferred embodiment of the inventiona particularly high level of wearing comfort is achieved in that thesurface portions of the contact element, which come into contact withthe surface of the skin of the user of the mask, have a surface which isvelvety matt. In accordance with a particularly preferred embodiment ofthe invention, at least in the region of the contact surface of thecontact element, there is provided a surface structure for affording aself-cleaning effect. Such a surface structure may have for examplelotus leaf surface structures. The contact element may also be providedwith a gel body, at least in the region of the contact surface.

In accordance with a further aspect of the invention In accordance withthe invention the object specified in the opening part of thisspecification is attained by an application device for a breathing maskarrangement comprising a forehead support device, wherein the foreheadsupport device has a right arm element and a left arm element and thearm elements are provided with a contact portion provided for bearingagainst a left and right forehead zone respectively and each of the armelements is arranged pivotably movably about a pivot axis.

That advantageously makes it possible for the breathing mask arrangementto be supported in the forehead region of the mask user by way of aforehead support device which can advantageously be adapted to differentfacial architectures.

In accordance with a particularly preferred embodiment of the inventionthere is provided an adjusting drive device for deflection of the armelements into a predetermined pivotal position. The adjusting drivedevice is preferably designed in such a way that both arm elements arepivotable by way of the adjusting drive device simultaneously, that isto say at the same time. The adjusting drive device may include forexample an adjusting wheel which, by way of a screw or spiral drivemeans, is in engagement with actuating members which are displaceableradially with respect to an axis of rotation of the pivot wheel.

Preferably the pivot axes of each of arm elements are directed in such away that viewed in the application position in a front view, they extendtransversely and in particular perpendicularly with respect to atransverse line joining the eyebrows. That advantageously makes itpossible for the forehead support device to be precisely adapted to thecurvature of the forehead of the user of the mask and thereby toprecisely set the breathing mask which is held by the application devicein the region of the contact zone of the sealing lip device, whichcontact zone crosses over the bridge of the nose.

In accordance with a particular aspect of the present invention each ofthe arm elements is pivotable about its own pivot axis associatedtherewith, wherein the pivot axes of the two arm members are spaced fromeach other at the level of a transverse line joining the eyebrows. Thespacing of two pivot axes of the arm members is preferably between 10and 50 mm at the level of the transverse line joining the eyebrows. Thelength of the arm members is between about 25 and 75 mm depending on therespective spacing of the pivot axes.

In accordance with a further aspect of the present invention,adaptability, which is still further increased in comparison with theabove-described embodiment, of the forehead support device to theindividual curvature of the forehead of the user of the mask, isachieved if the pivot axes of the arm members are inclined relative toeach other through an angle α in the range of between 8 and 45° relativeto each other. It is advantageously possible for the structure definingthe pivot axes to be designed in such a way that the angle α of thepivot axes relative to each other is adjustably variable.

Preferably the pivot axes are established in such a way that, inrelation to a front view of a user of the mask, they intersect in theregion between the transverse line joining the eyebrows and the chin ofthe user of the mask. That affords particularly good compatibility inrelation to the facial architectures which statistically predominantlyprevail.

The pivot axes are preferably each defined by a respective hinge device.The hinge devices can be in the form of multi-part pivot arrangementsor, in accordance with a particularly preferred embodiment of theinvention, they can be in the form of film hinges. With that embodimentit is possible for the arm members and the hinge basic structuresprovided for pivotably mounting the arm members to be produced in onepiece, that is to say integrally from a plastic material.

In accordance with a particular aspect of the present invention theadjusting drive device includes an adjusting wheel which is coupled byway of a spiral structure to actuating members by means of which the armelements can be deflected into defined pivotal positions. The adjustingwheel is preferably mounted rotatably about an axis which in theapplication position of the application device is oriented substantiallyperpendicularly to the surface of the forehead of the patient. Theadjusting wheel is preferably of a diameter in the range of between 20and 50 mm and in the outside peripheral region it is provided with aprofiling, preferably a fluted or grooved structure, which permits thereliable transmission of the finger forces required for rotating theadjusting wheel. The adjusting wheel is preferably arranged in anintermediate region between a respiratory gas conduit portion of thebreathing mask arrangement and a base portion of the forehead supportdevice. In that case it is possible for the finger forces which arerequired to rotate the adjusting wheel to be applied by way of the thumband the index finger, in which case the respiratory gas conduitassociated with the breathing mask arrangement is embraced by thefingers, by using the thumb and the index finger.

In accordance with a further aspect of the invention, in accordance withthe invention the object thereof as set forth in the opening part ofthis specification is also attained by an application device for abreathing mask arrangement having a forehead support device, wherein theforehead support device has a right arm element and a left arm elementand both arm elements are pivotably movably coupled to a breathing maskby way of a pivot axis, wherein the pivot axes extend substantiallyparallel to a transverse line which in the application position of thebreathing mask arrangement joins the eyebrows of a user of the mask andthere is provided an adjusting drive device for establishing the pivotalposition of the arm elements.

In that way it is advantageously possible, by way of the foreheadsupport device, to adjust the contact pressure of a zone of the sealinglip device, which passes across the bridge of the nose of a user of themask.

BRIEF DESCRIPTION OF THE DRAWINGS

Further details and features of the invention will be apparent from thedescription hereinafter with reference to the drawings in which:

FIG. 1 shows a perspective view of a breathing mask arrangementaccording to the invention,

FIG. 2 shows a further perspective view of the breathing maskarrangement according to the invention without hose connecting sleeve,

FIG. 3 shows a perspective view of the application structure of thepreviously illustrated breathing mask arrangement,

FIG. 4 shows a perspective view of the application structure with adocking port connected thereto,

FIG. 5 shows a perspective view of an integral member formed from acarrier portion and a frame portion,

FIG. 6 shows a further perspective view of the integral member shown inFIG. 5 to describe the latching device provided for coupling the dockingport,

FIG. 7 shows a side view of the breathing mask arrangement according tothe invention,

FIG. 8 shows a simplified perspective view of a forehead support devicewith two pivotably mounted pad-like contact elements and by way ofindication a breathing mask,

FIG. 9 shows a simplified sectional view to illustrate a preferredembodiment of a pivotably mounted contact element,

FIG. 10 shows a plan view of two contact elements which are formedintegrally with each other, each of which is individually provided witha pivotal mounting means,

FIG. 11 shows a further embodiment of a contact element with a concavelycurved contact surface and a part-spherical portion for pivotablymounting the contact element,

FIG. 12 shows a sketch to describe a preferred distribution of surfacepressure from a central region of the contact element in its variationfrom a centre region of the contact element towards the edge regionthereof,

FIG. 13 shows a front view of the face region of a person to explainpreferred contact zones of the forehead support device and preferredorientations of the pivot axes which are crucial in terms of pivotalmounting of the arm elements,

FIG. 14 is a perspective view to explain an adjusting drive device foradjustably pivoting the arm elements,

FIG. 15 shows a detail view to describe the structure of a variant ofthe adjusting drive, which is provided with film hinge structures,

FIG. 16 shows a further detail view to describe an embodiment of theadjusting drive device also with a film hinge and a spiral groove regionwhich is provided at an underside of the adjusting wheel and which isdirectly in engagement with an engagement portion of an arm element,

FIG. 17 shows a simplified view in section of a further embodiment of anadjusting drive device with an arm element which is mounted pivotably byway of a pivot pin zone,

FIG. 18 shows a simplified side view of an application device providedwith a breathing mask arrangement,

FIG. 19 shows a simplified perspective view of an application devicewith integrated forehead support device for the application of abreathing mask,

FIG. 20 shows a side view of a breathing mask application device with abreathing mask arrangement pivotably movably accommodated therein,

FIG. 21 shows a detail view of a holding portion of an applicationdevice, which is provided for coupling to a breathing mask arrangement,

FIG. 22 shows a perspective view of an application device for abreathing mask arrangement as can be fitted for example onto arespiratory gas conduit portion of a breathing mask,

FIG. 23 is a perspective view of a forehead support device with aheadband portion and a coupling structure connected thereto forsupporting a conduit portion,

FIG. 24 shows a perspective view of a further embodiment of a foreheadsupport device with an adjusting mechanism for adjusting the foreheadspacing and the lateral position of a conduit portion,

FIG. 26 shows a detail view of an end region of a forehead contactportion with a loop support which terminates flat,

FIG. 27 shows a partial diagrammatic view to illustrate a screw spindlevariant of an adjusting drive as can be used for example in theembodiment shown in FIGS. 24 and 25,

FIG. 28 is a diagrammatic view to illustrate a conduit portion made fromelastomer material with an integral mask connecting socket which can besupported in a forehead support device,

FIG. 29 shows a sectional view to illustrate a variant of the foreheadsupport portion, which is of a cushioned configuration by virtue ofpores or caverns,

FIG. 30 is a sectional view through a connecting region formed in theregion of the forehead support, between the connecting portion of abreathing mask and a conduit portion (here the mask-side socket of awashing-out adaptor—AEROCLICK (registered trade mark of MAPMedizin-Technologie GmbH); Wisper-Swivel (Respironics));

FIG. 31 is a diagrammatic view to illustrate a further variant accordingto the invention of a forehead support device,

FIG. 32 shows an embodiment of a connecting adaptor with foreheadsupport adjustably pivoted thereto,

FIG. 33 shows a bent wire variant of the forehead support of FIG. 32,

FIG. 34 shows a screwthread sleeve/spindle variant of the adjustingdevice of FIG. 32,

FIG. 35 shows an embodiment of a breathing mask arrangement with a tubeportion which is steplessly variable in curvature—and a forehead supportdevice coupled thereto,

FIG. 36 shows a side view of a further variant of a variable-curvatureconduit portion, and

FIG. 37 shows a perspective view of a headband arrangement in particularfor use with the forehead support devices described hereinbefore.

DETAILED DESCRIPTION OF THE DRAWINGS

The breathing mask arrangement shown in FIG. 1 includes a sealing lipmeans 1 made from an elastomer material, in particular silicone rubber,and an arch body 2. The sealing lip means 1 is designed in such a waythat it lines a receiving opening provided to receive the nose region ofa user of the mask, and in that situation preferably passes across thebridge of the nose and the upper lip region of the user of the mask. Inthis case the sealing lip means 1 is of a substantially saddle-shapedsilhouette. In this embodiment, the sealing lip means 1 and the archbody 2 are made in one piece from an elastomer material and areaccommodated in a frame portion 3.

The frame portion 3 is made from a plastic material and has holdingclips or loops 4 which are produced integrally therewith. In theapplication position of the breathing mask arrangement the holding loops4 are disposed at cheek level or at the level of the sides of the noseof the user of the mask and permit coupling of a lower web bandarrangement. For reliably coupling the arch body 2 to the frame portion3, there is a retaining structure 5, by way of which the arch body 2 canbe fixed to the frame portion 3 in the joining position by latchingengagement therein. The retaining structure 5 includes a retaining nose5 a which engages over a top side of the frame portion 3.

Provided on the arch body 2 are a plurality of outlet openings 6 for thedischarge of used respiratory gas to the ambient atmosphere.

The breathing mask arrangement further includes a carrier portion 7which in this embodiment is formed integrally with the frame portion 3.

A respiratory gas conduit member which here is in the form of a dockingport 8 is releasably fixed to the carrier portion 7. The docking port 8includes an annular flange (not visible here) on to which a hoseconnecting sleeve 9 is rotatably movably fitted. The hose connectingsleeve 9 includes a hose connecting portion 9 a on to which an endportion of a respiratory gas hose can be fitted.

The breathing mask arrangement according to the invention furtherincludes a forehead support device 10 which is coupled movably to theframe portion 3 by way of an adjusting device 11.

The adjusting device 11 is of such a configuration that it permits apivotal movement of the forehead support device 10 with respect to theframe portion 3 about the pivot axis X which is shown here. Theadjusting device 11 includes a fixing mechanism, by which the foreheadsupport device 10 and the frame portion 3 can be fixed in the selectedrelative position.

The forehead support device 10 includes a loop portion 12 to whichforehead cushion elements 14 can be mounted. Provided on the loopportion 12, similarly to the frame portion 3, are holding loops or clips15, for coupling the loop portion 12 to an upper web band arrangement ofa headband provided for fixing the breathing mask arrangement in place.

The forehead cushion elements 14 are made from an elastomer materialand, on their underside 14 a which in the application position facestowards the user of the mask, form a contact surface involving apredetermined distribution in terms of surface pressure. The foreheadcushion elements 14 are each coupled to the loop portion 12 by way of arespective push-in foot 16. The push-in foot 16 is providedeccentrically on the respective forehead cushion element 14 in such away that pivoting the forehead cushion elements 14 about the axis 17 ofthe push-in foot, as indicated by the arrow P, makes it possible toachieve different contact positions for the underside 14 a of theforehead cushion elements 14 on the surface of the forehead of the userof the mask. Different contact positions can be achieved by virtue ofselection of the pivotal position of the forehead cushion element 14 andby virtue of selection of the receiving opening 18 provided to receivethe push-in foot 16. In the embodiment illustrated here, two mutuallyspaced receiving openings 18 are provided in the loop portion 12, foreach of the left and the right forehead cushion elements 14.

The forehead cushion elements 14 can be removed from the loop portion 12by pulling the push-in feet 16 out of the receiving openings 18, as isshown in FIG. 2. In this embodiment, the centre lines of the receivingopenings 18 are spaced from each other by approximately 10 mm. Theeccentricity of the push-in foot 16 on the respective forehead cushionelement 14 (see in that respect FIG. 1) is also about 10 mm. As a resultof the eccentric arrangement of the push-in foot 16 and the spacedarrangement of the receiving opening 18, heightwise variability of theforehead cushion elements in a range of about 30 mm is achievedsubstantially perpendicularly to a line joining the eyebrows of the userof the mask. A variation in the contact position over a range of 20 mmis also possible in a lateral direction, that is to say in the directionof the above-mentioned line which joins the eyebrows. The holding loop15 provided for coupling an upper web band arrangement is arranged inthe proximity of the receiving openings 18 in such a way that thethrough opening 15 a defined by the holding loop is covered over towardsthe user of the mask by the forehead cushion element 14.

In the view shown in FIG. 2 the hose connecting sleeve 9 shown in FIG. 1has been removed from the docking port 8. It is possible in this view tosee an annular flange 19 which is formed integrally with the dockingport 8 and which has a plurality of tongue elements 19 a which areelastically deflectable towards the centre of the through passage formedby the docking port 8. Provided on the tongue elements 19 a is aretaining bead or ridge 20 which can be brought into engagement with aninternal peripheral groove provided in complementary relationship on thehose connecting sleeve 9. The geometry of the retaining bead 20, theinternal peripheral groove in the rotational sleeve 9 and the elasticityof the tongue elements 19 a are so matched that the hose connectingsleeve 9 can be withdrawn from the annular flange 19 without involvingthe use of a tool, when a given pulling force is exceeded. The annularflange 19 and the hose connecting sleeve 9 are also designed to fit insuch a way that the hose connecting sleeve 9 is easily rotatably carriedon the annular flange 19.

In this embodiment the docking port 8 is provided with hose connectingportions 21, 22, on to which a plug or hose element can be fitted. Thehose connecting portions 21, 22 each form a respective through passagewhich opens into the respiratory gas passage formed in the docking port8. When not in use, the hose connecting portions 21, 22 can be closed bya plug or cap element (not shown) which is preferably fitted infrictionally locking relationship on the hose connecting portions 21,22. In this embodiment the hose connecting portions 21, 22 are arrangedrecessed in a groove which is delimited by two upstanding groove walls23, 24. The docking port 8 is coupled to the carrier portion 7 by way ofa plug-in connecting structure.

The retaining connecting structure for coupling the docking port 8 tothe carrier portion 7, as can be seen from the view in FIG. 3, in thisembodiment, is in the form of a rotary latching or bayonet connectingstructure 25. The bayonet connecting structure 25 includes two mutuallydiametrally opposite retaining bridges 27 which are separated from eachother by insertion recesses 26. In the locking position the retainingbridges 27 come into engagement with two retaining projections which areprovided on a push-in flange portion 28 (FIG. 4) of the docking port.

The carrier portion 7 is formed integrally with the frame portion 3 andin that respect forms the insert opening which is provided to receivethe insert connection 28 and which is partially lined by the retainingbridges 27. Provided in the transitional region between the carrierportion 7 and the frame portion 3 are two guide flanks 30 which are alsoprovided integrally with the frame portion 3 and form part of theadjusting means 11. The guide flanks 30 form an arcuate guide means 31in which a coupling portion 32 of the forehead support device 10 isdisplaceably guided. The arcuate guide means 31 and the region of thecoupling portion 32, which is guided therein, are such that the foreheadsupport device 10 and the frame portion 3 are movable relative to eachother about the pivot axis X already shown in FIG. 1. Provided at theguide flanks 30 is an actuating zone 33, for applying a release forcefor moving the adjusting means 11 into a release position. The releaseforce can be applied to the actuating zone in particular when grippingaround the docking port 8 with the thumb and the index finger andapplying the corresponding fingertips. As an alternative to the arcuateguide means 31 provided here, it is also possible for the adjustingmeans 11 to be of such a configuration that relative movement is madepossible between the forehead support device 10 and the frame portion 3along a path of movement which differs from an arcuate path. It is alsopossible to mount to the forehead support device 10 forehead cushiondevices which in their structure differ from the forehead cushionelements 14 shown in FIG. 1.

FIG. 4 shows the application structure of the breathing mask arrangementaccording to the invention, in an assembly condition in which thedocking port 8 according to the invention is inserted into the insertopening formed in the carrier portion 7 and correctly fixed in positionby way of the bayonet closure device provided in the region of theinsert opening. In this embodiment, the docking port 8 forms a conduitmember which is in the nature of a pipe bend and by which the flow ofrespiratory gas flowing by way of the hose connecting sleeve 9 (FIG. 1)is diverted through an angle of about 30° towards the tip of the nose ofthe user of the mask. Feeding the respiratory gas in that way to theinternal space in the mask, which is defined by the arch body 2 (FIG.1), provides that the gas advantageously flows over the bridge of thenose of the user of the mask.

The modular structure of the breathing mask arrangement according to theinvention makes it possible to implement a configuration of thebreathing mask arrangement, which takes better account of the respectivesituation of use. The docking port 8 which is fitted into the carrierportion 7 has an insert connecting portion 28 which projects beyond thecarrier portion 7 towards the frame portion 3. An insert opening portionof the arch body 2 can be fitted on to the insert connecting portion 28,with slight elastic expansion. Provided on the insert connecting portion28 is a peripheral bead 34, by which the arch body 2 and the insertconnecting portion 28 are held in a defined joint position. Thatperipheral bead 34 can come into engagement with an internal peripheralgroove correspondingly provided in the arch body 2, or it can fit on aninternal surface of the arch body 2. The carrier portion 7 and thedocking port 8 are of such a configuration that the docking port 8 formsa respiratory gas conduit portion which bridges over the region of thebridge of the nose. That ensures that the field of vision is onlyslightly impaired.

FIG. 5 shows a further perspective view of the integral member formingthe frame portion 3. The guide flanks 30 which are made in one piecewith the frame portion 3 are of such a configuration that application ofa release force to the actuating zones 33 urges the guide flanks 30 awayfrom each other in the region of the arcuate guide means 31. In thepresent embodiment, for that purpose, a lever/tilting effect is producedby an arcuate leg 35. The return movement of the guide flanks 30 in theregion of the arcuate guide means 31 takes place as a consequence of theelasticity of the material involved. The fixing effect can be achievedby virtue of frictionally locking clamping of the contact zones of thecoupling portion 32, which are guided between the guide flanks 30. As analternative thereto or in combination therewith, it is also possible toachieve the fixing effect by coupling in positively locking engagement,for example by the adoption of a fine tooth arrangement.

Preferably, there is provided an abutment device which limits themaximum range of pivotal movement of the forehead support device 10 withrespect to the frame portion 3. It is possible for that abutment deviceto be so designed that, for example by increasing the actuating forcesapplied to the actuating zone 33, the abutment device is moved into acondition in which the forehead support device 10 can be separated fromthe pivot structure connected to the frame portion 3.

The view illustrated in FIG. 5 also shows an outwardly recessed region36 in the frame portion 3, which improves positioning and fixing of thearch body 2 in the frame portion 3. Positioning of the arch body 2 inthe frame portion 3 is further promoted by two fixing plates 37 whichare provided in the region of the holding loops 4 at the underside ofthe frame portion 3 and which engage into clamping pocket portionsprovided in the transitional region of the sealing lip means 1 in thearch body 2. The frame portion 3 is of a substantially saddle-shapedsilhouette and attains its maximum width in a region of the frameportion 3, which in the application position of the breathing maskarrangement is approximately at the height of the sides of the nose ofthe user of the mask. The holding loops 4 extend upwardly from that zoneB of maximum width to the region of the eyes of the user of the mask.The inward edges of the through openings which are bordered by theholding loops 4 are of a rounded configuration in order to prevent theband portions which are passed through those openings from possiblybeing chafed through. This view again shows the latching device adaptedfor fixing the docking port in the carrier portion 7.

FIG. 6 shows the fixing plates 37 which are provided at the underside ofthe frame portion 3, from another perspective. The fixing plates 37 areof a thickness t as measured transversely to the joining direction inthe range of from 0.8 to 3 mm. The fixing plates are of a taperedconfiguration in the joining direction. The fixing plates 37 and inparticular also the internal peripheral region of the frame portion 3,which region bears against the arch body 2, can be provided with aprofiling which still further assists with coupling of the arch body.Preferably, fine profile grooves extending in the peripheral directionof the frame portion 3 are provided on the frame portion 3 and on theportion of the arch body 2, which bears there against.

The bayonet connecting structure 25 on the carrier portion 7 includes anend abutment 38 for defining the end position of the docking port 8 inthe coupling position. In this embodiment the bayonet connectingstructure 25 is designed in such a way that the maximum fixing force isachieved in the end position defined by the end abutment 38.

FIG. 7 shows the breathing mask arrangement according to theinvention—with the exception of the forehead cushion elements 14 (FIG.1)—in the completely assembled condition, from the direction of thepivot axis X. As can be seen in that view the docking port 8 which inaccordance with the invention can be releasably inserted into thecarrier portion 7 forms a coupling element for coupling the elastomerarch body 2 to a rotatably supported hose connecting sleeve 9, by whichthe feed flow of respiratory gas is deflected through an angle α whichin this embodiment is 32°.

The docking port 8 can be selected from a set which includes a pluralityof docking ports 8 and forms an interface member by which the arch body2 can be coupled to different hose systems. Compatibility with differentrespiratory gas conduit systems can also be ensured by way of the hoseconnecting sleeve 9 which is fitted on to the docking port 8. It ispossible to provide a plurality of sealing lip means which arerespectively adapted to given types of faces and to achieve aconfiguration which is appropriate to the requirements involved, for thebreathing mask arrangement according to the invention, in that anelastomer element which takes particularly good account of theindividual facial architecture of the user of the mask and whichcomprises the sealing lip means 1 and the arch body 2 is integrated intothe mask arrangement according to the invention. It is also possible toprovide a plurality of variants of the forehead support device, whichhowever are compatible with the adjusting means 11, and to fit the maskarrangement according to the invention with a variant of the foreheadsupport device 10 which takes particularly good account of theindividual facial architecture. As an alternative to the foreheadcushion elements shown in FIG. 1, the forehead support device 10 mayalso be fitted with other kinds of forehead cushion devices forcushioned contact against the forehead of the user of the mask. It ispossible to integrate cushion devices of that kind, for example into anupper forehead band arrangement, and to fit the forehead support deviceon to that cushioned forehead band arrangement, for example by way of ahook-and-loop fastener structure.

The invention is not limited to the preceding embodiment. By way ofexample, it is also possible to fit into the frame portion 3 which isdesigned in accordance with the invention, an arch body 2 which is notmade from an elastomer material.

The forehead support device shown in FIG. 8 has a holding device 41 forpivotably holding a contact element 42. The holding device 41 for thatpurpose includes a pivotable holder 43 which here has a plurality offixing elements 44 which form part of a ball joint arrangement.

In the embodiment illustrated here, the contact element 42 is of aplate-like configuration and is formed from an elastomer material, herefully transparent silicone rubber. The contact element 42 is mountedtiltably about at least two axes in space by way of the fixing elements44. In order to ensure as easy mobility as possible of the contactelement 42, provided between the fixing elements 44 and a fixing shankportion (not visible) of the contact element 42 is a ring body which hasa spherical external surface (details in relation thereto will bedescribed more fully with reference to FIG. 9).

The holding device 41 further includes a coupling portion 45 forcoupling the holding device 41 to a breathing mask 46.

In the embodiment illustrated here the coupling portion 55 is in theform of a ring-like element which can be fitted directly on to aconnecting portion 47 of the breathing mask 46, the connecting portion47 being of a correspondingly complementary configuration. In theembodiment illustrated here the holding device 41 is provided with afixing portion 48 and can be connected by way thereof to a headband.

FIG. 9 shows a preferred embodiment of the contact element 42. Thecontact element 42 is formed from an elastomer material and has acontact surface 49 which is slightly concavely curved. The contactelement 42 is provided with a plurality of fine through bores 50 throughwhich pressure equalisation with the ambient atmosphere can be achievedin respect of the intermediate space possibly defined between thecontact element 42 and the forehead of the patient. That advantageouslyprevents the contact element 42 from being sucked against the foreheadregion of the patient.

In the embodiment illustrated here the contact element 42 has a shankportion 51. Provided on the shank portion 51 is a ring element 52 whichforms a spherical external surface. In conjunction with that ringelement 52, this arrangement affords a comparatively easily movable balljoint device. As an alternative thereto it is also possible to foregothe ring element and to provide the corresponding spherical portiondirectly on the shank portion 51 of the contact element 42.

The embodiment of the invention shown in FIG. 10 has two contactelements 42 which are connected together by way of an integral centralbridge or strap 54. The central strap 54 is so designed that it stillpermits pivotal movement and tilting movement of the two contactelements 42 relative to each other over a sufficient angular range. Thespacing of the centres of the two contact elements 42 from each otherpreferably approximately corresponds to the distance between the eyes ofthe user of the mask.

FIG. 11 shows a further embodiment of a contact element 42, in whichcase tiltability of the portion of the contact element, which forms thecontact surface, is achieved by way of an elastomer structure 55 whichhere is formed integrally with the contact element 52. In the embodimentillustrated here the elastomer structure includes a substantiallyspherical internal space which can be fitted on to a spherical trunnionportion, with temporary elastic expansion. In the embodiment illustratedhere the contact element also has a concavely curved base body which isflattened when the contact element is appropriately fitted in position.

The curvature of the base body of the contact element is preferably soselected that a defined distribution in terms of contact pressure isafforded when it is applied to a flat surface. That distribution inrespect of contact pressure is shown by way of example in FIG. 12. Thelower curved line a1 in this case symbolises the contact surface of thecontact element in its initial position. The line a2 which is shown hereas being straight symbolises the contact surface of the contact element42, when appropriately deformed in the application position. Thedistribution in terms of surface pressure, which is indicated here insimplified form by an assembly of arrows 56, occurs in the context ofdeformation of the contact surface of the contact element. Thedistribution in terms of surface pressure is selected here in such a waythat, starting from the centre Z towards the edge region, there isinitially a substantially uniform distribution in terms of surfacepressure, with the surface pressure gradually decreasing in the regionof r/5 towards the edge R.

The invention is not limited to the embodiments described hereinbefore.For example, it is also possible, in a departure from the plate-shapedconfiguration selected here, for the forehead contact elements to be ofa rectangular or polygonal configuration.

FIG. 13 shows a front view illustrating the surface of the face of auser of the mask. For application or fitting of a breathing maskarrangement it is applied for example to the face of the mask user insuch a way that a sealing lip contact zone 201 defined by a sealing lipdevice of the breathing mask arrangement and the surface of the face ofthe mask user, starting from the upper lip region 202, extends aroundthe nostrils 203 to the bridge of the nose 4 and preferably passesacross same at the level of the eyes.

The breathing mask arrangement is supported on the forehead region ofthe mask user by way of a forehead support device which will bedescribed in greater detail hereinafter. Preferably support on theforehead region is implemented by way of two contact zones 207, 208which are disposed above a transverse line 206 which joins the eyebrows205. In the view illustrated here support for the breathing maskarrangement in the forehead region is implemented at two contact zones207, 208, wherein the spacing of the centroids S1, S2 of the contactzones 207, 208 preferably approximately corresponds to the spacingbetween the eyes of the mask user. The contact pressure of the sealinglip device of the breathing mask arrangement in the region of thesealing lip contact zone 201 is adjustably variable insofar as contactelements provided for affording contact in the contact zones 207, 208are pivotable about pivot axes X0, X1, X1′, X2, X2′ and preferably alsoabout a transverse axis Y0.

Support for the breathing mask arrangement on the face of the mask usercan be implemented by the application device which is described ingreater detail hereinafter, in such a way that the breathing maskarrangement and the forehead support device are supported on the face ofthe mask user substantially at three mutually spaced zones. In theforehead region in that case the forehead support device is supported atthe contact zones 207, 208. The breathing mask arrangement is supportedon the face of the mask user by way of the sealing lip contact zone 201.The fact that the application device and the breathing mask arrangementare supported on the face of the mask user at three main supportingzones advantageously provides that the breathing mask is supported in astatically defined manner. The holding forces required for holding theforehead support device in the forehead region are preferably applied byway of an upper headband arrangement. For fixing the breathing maskarrangement in the nose region, there is preferably a lower beltarrangement, by way of which the breathing mask arrangement is urgedagainst the surface of the face of the mask user by pulling forces 209and 210 which act thereon at both sides and which are directed laterallyrelative to the cheeks. The pulling forces 209, 210 are preferablyapplied by a lower belt arrangement which is passed around the region ofthe back of the head of the mask user.

The pivot axes X0, X1, X1′, X2, X2′ which permit adjustment of thesupport configuration of the forehead support device preferably extenddirected away from the forehead region towards the upper lip region 202of the user of the mask. The axes X1, X2 which are shown here areoriented in mutually parallel relationship and spaced from each other bya spacing a which substantially corresponds to the width of the bridgeof the nose, in particular the width of the bridge of the nose in theregion of the tear duct openings of the mask user.

The pivot axes X1′, X2′ which are inclined relative to each other hereare also preferably spaced in the region of the width a of the bridge ofthe nose, at the level of the contact zones 207 and 208. The axes X1′,X2′ are inclined relative to each other at an angle α which ispreferably so selected that the two axes intersect in the region betweenthe base of the nose and the chin 211 of the mask user.

FIG. 14 as a perspective view shows an adjusting drive 212, by way ofwhich the pivotal position of a left arm element 214 and a right armelement 215 can be altered adjustably with respect to a base portion216.

In this case the adjusting drive 212 includes a coupling member 217associated with the left arm element 214 and a coupling member 218associated with the right arm element 215.

Each of the two coupling members 217, 218 is provided with at least oneengagement portion 219, 221 which is in engagement with an adjustingwheel 222 which is shown here in a position of having been lifted off,by way of a spiral structure 223 provided at the underside of theadjusting wheel 222 (see the sketch at bottom right). By rotating theadjusting wheel 222 about its axis of rotation 224, the engagementportions 219, 221, as indicated by the arrow symbols 225, 226, aredisplaced in the radial direction jointly with the coupling members 217,218.

In the illustrated embodiment the coupling members 217, 218 are coupledmovably to the left and right arm elements 214, 215 respectivelyassociated therewith. In the illustrated embodiment coupling of thecoupling members 217, 218 to the arm elements 214, 215 associatedtherewith is effected in each case by way of a hinge portion 227 and 228respectively which permits a pivotal movement of the coupling member217, 218 with respect to the arm element 214, 215 associated therewith.The arm elements 214, 215 are coupled to the base portion 216 by way ofa hinge connection 229, 230. The hinge connections 229, 230 are here inthe form of film hinges. In this case the arm elements 214, 215 areformed integrally with the base portion 216. The hinge connections 229,230 define the pivot axes X1, X1′ and X2, X2′ respectively referred tohereinbefore in connection with FIG. 1. As a consequence of the pair offorces applied to the respective arm element in the region of the hingeportions 227, 228 and the hinge connections 229, 230, the respective armelement can be moved with respect to the base portion 216 into a pivotalposition which is defined by the radial spacing of the engagementportion 219, 221 from the axis of rotation 224. The maximum radialstroke movement of the engagement portions 219, 221 and the spatialposition of the hinge portions and the hinge connections 227, 228, 229,230 are so selected that, for example in a range of rotary movement ofthe adjusting wheel 222 through an angle of rotation of 540°, it ispossible to adjust a pivot angle .beta. of the arm elements 214, 215 inthe range of from 0 to 40°.

The adjusting wheel 222 is made from a plastic material and fitted byway of a central rotary trunnion or projection (not visible here) into abore 231 provided in the base portion 216. Here the adjusting wheel 222is of a diameter of 45 mm and on its outside it is provided with amarking 232 which indicates the adjusting effect achieved by rotatingthe adjusting wheel 222.

In the embodiment illustrated here the base portion 216 is coupled byway of a further hinge connection 233 to a holding portion 234. Thehinge connection 233 illustrated here defines the pivot axis Y0indicated in FIG. 13. The pivotal movement of the holding portion 234with respect to the base portion 216 is effected in the same manner asdescribed hereinbefore with respect to the left and right arm elements214, 215 by way of a coupling member 235 which is in engagement with theadjusting wheel 222 by way of an engagement portion 236 and is movablein the radial direction with respect to the axis of rotation 224, asindicated by the arrow symbol 237. The holding portion 234 is connectedto a mask base body portion of a breathing mask arrangement by way of anintermediate structure which is not shown in detail here.

Mounted to the left and right arm elements 214, 215 as will be describedin greater detail hereinafter, are contact pads by way of which the armelements 214, 215 bear against the contact zones 207, 208 (FIG. 13) ofthe mask user.

As will also be described in greater detail hereinafter, the armelements 214, 215 can be pulled onto the forehead region of the maskuser preferably by way of an upper headband arrangement.

FIG. 15 shows a further variant of the adjusting drive 212 in which acoupling member 218 which is movable radially relative to the axis ofrotation 224 of the adjusting wheel 222 is formed in one piece with thearm element 215 associated therewith, in which case sufficient pivotalmobility is achieved by way of a film hinge structure 238. The baseportion 216 is also formed in one piece with the arm element 215 and iscoupled thereto similarly to the embodiment shown in FIG. 14 by way of ahinge connection 230 which is also in the form of a film hinge. Theportions at which forces are applied, as defined by the film hingestructure 238 and the hinge connection 230, are spaced from each otherin such a way that, as a consequence of the radial stroke movement ofthe coupling member 218 which can be adjusted by the adjusting wheel222, it is possible to achieve an adequate pivotal angle .beta. of thearm element 215.

The adjusting wheel 222 is rotatably mounted on a rotary trunnion orprojection 239 which stands up from the base portion 216. The undersideof the adjusting wheel 222, which faces towards the base portion 216,has the spiral structures, like the above-described embodiment, whichare in engagement with the engagement portion 221 provided integrallywith the coupling member 218.

FIG. 16 sets out a further embodiment of the adjusting drive 212. Inthis case also the adjusting drive 212 includes an adjusting wheel 222coupled rotatably to the base portion 216 by way of a rotary trunnion orprojection 240. Provided on the underside of the adjusting wheel 222,which faces towards the base portion 216, is a spiral structure 241which is directly in engagement with an engagement portion 219′ providedon the arm element 214. The arm element 214 is pivotably movably coupledto the base portion 216 by way of a hinge connection 229 which in thiscase also is in the form of a film hinge. Rotation of the adjustingwheel 222 about the axis of rotation 224 defined by the rotary trunnion214 makes it possible to set different spacings of the engagementportion 219′ from the axis of rotation 224, whereby the arm element 214is pivotable with respect to the base portion 216 into respectivelydesired pivotal positions.

FIG. 17 shows a further embodiment of an adjusting drive 212 accordingto the invention, in which the base portion 216 and the arm element 214are in the form of separate parts which are coupled together by way of ahinge device 243. Provided on the arm element 214 is a knob 244 to whichthe coupling member 217 is pivotably mounted. Similarly to theembodiments described hereinbefore, the coupling member 217 has anengagement portion 219 which is in engagement with the adjusting wheel222 by way of a spiral structure 223. By rotation of the adjusting wheel222, the coupling member 217 can be displaced in a defined manner in theradial direction and, in so doing, pivots the arm element about thehinge device 243 into a defined angular position with respect to thebase portion 216. It is possible to provide braking means, by which theadjusting wheel 222 is sufficiently firmly fixed in the desiredrotational position. Braking devices of that kind can be embodied forexample by fine latching or detent projections which come into and outof engagement respectively in the course of a relative movement of thecomponents which are moved relative to each other, such movement beingmade possible by the inherent elasticity of the parts involved. It isalso possible for the spiral structure to be designed in such a way thatit is substantially self-locking.

FIG. 18 shows an application device according to the invention with abreathing mask arrangement 244 accommodated therein. The breathing maskarrangement 244 includes a mask base body 245 and a sealing lip device246 which is coupled thereto. The sealing lip device 246 is made from anelastomer material, preferably fully transparent silicone rubber, and inthe application position sealingly contacts the sealing lip contact zone201 of the mask user, as is shown in FIG. 13. The feed of therespiratory gas into the interior of the mask which is defined by themask base body 245 is effected by way of a flexible conduit portion 247which in the illustrated embodiment is also made from an elastomermaterial and is in the form of a bellows structure. Connected to theflexible conduit portion is a breathing hose connecting portion 248which is of an inside diameter in the range of between 12 and 35 mm. Thebreathing hose connecting portion 248 is coupled to the base portion 216of the forehead support device. The forehead support device 216 includesthe adjusting wheel 222 which here is disposed in an intermediate regionbetween the flexible conduit portion 247 or the breathing hoseconnecting portion 248 and the base portion 216. The adjusting wheel 222can be turned by the user of the mask by gripping around the flexibleconduit portion 247, by way of the fingertips of the thumb and the indexfinger of the user of the mask. Rotating the adjusting wheel 222 makesit possible for the arm elements 214 and 215 to be pivoted about thepivot axe Xn. In that way it is possible for a forehead pad 249 which isprovided for making contact with the forehead region of the mask user tobe adjustably positioned with respect to the base portion 216. Providedon the arm element 215 (214) is an eye portion 250, through which aportion of an upper headband arrangement 251 is passed.

In the embodiment illustrated here the base portion 216 is pivotablymovably connected to a holding portion 234 by way of the hingeconnection 233. The holding portion 234 is of a frame-like configurationand embraces the mask base body 245 at least in the side region thereof.Also provided on the holding portion 234 are eye portions 250 throughwhich a portion of a lower headband arrangement (not shown) can bepassed. As an alternative to the design configuration involving the eyeportions 252 or also in combination therewith, it is possible to provideother coupling structures for coupling the holding portion 234 or themask base body 245 to a headband arrangement.

Pivotal movement of the base portion 216 about the pivot axis Y0 whichis defined by the hinge connection 233 is effected in this embodimentsimultaneously with the pivotal movement of the arm members 214, 215about the axes X1, X2.

The breathing hose connecting portion 248 is coupled to the base portion216. In the present embodiment coupling is effected by way of a holdingfoot 253 which is guided past the adjusting wheel 222. The holding foot253 is fitted onto a plug connecting portion of the base portion 216 andprovided with a retaining device 254 by which an end portion of arespiratory gas conduit, which is coupled to the breathing hoseconnecting portion 248, is additionally fixed. The forehead pads 249intended to bear against the forehead of the mask user are displaceablymounted to the respective arm element 214, 215.

FIG. 19 shows an application device for a breathing mask, in which theleft arm element 214, the right arm element 215 and the holding portion234 can be tilted about the axes X1, X2 and Y0 respectively in a definedmanner by way of the adjusting drive 212 which is actuable by anadjusting wheel 222. The tilting movement of those components iseffected in each case by way of the coupling members 217, 218 and 235which are associated with those parts. Support for the arm elements 214,215 against the forehead region of a mask user is by way of the foreheadpads 249 which have already been referred to with reference to FIG. 18and which in this embodiment can be inserted into insert openings 255provided on the respective arm elements 214 and 215.

In this case the holding portion 234 is made from a high-strengthplastic material, preferably polyamide, and is of a frame-likeconfiguration. The holding portion 234 includes two holding arms 256,257 which are each provided with a respective eye portion 252 throughwhich an end portion of a lower belt arrangement can be passed.

The holding arms 256, 257 are provided with an engagement structure 258,259 by way of which the holding arms can be brought into engagement witha mask base body. Fixing of the mask base body in the holding portion234 is further effected by a retaining or latching projection 260 whichis formed integrally with the holding portion 234. Provided on a side ofthe base portion 216, which is remote from the holding portion 234, is apush-on portion 261, onto which a breathing hose connecting portion canbe fitted. The breathing hose connecting portion 248, as indicated inFIG. 18, can serve to conduct the respiratory gas into the interior ofthe mask, as is defined by a mask base body.

FIG. 20 shows an application device which is provided with a breathingmask arrangement 244 and which, similarly to the embodiments describedhereinbefore, includes an adjusting drive 212, by way of which the armelements 214, 215 which project on both sides from a base portion 216 ofthe adjusting drive 212, can be adjustably pivoted. In a departure fromthe embodiments described hereinbefore, in this case the mask base body245 is tiltable, independently of the adjusting movement of the armelements which is caused by the adjusting drive 212, about a pivot axisY1 which extends approximately in the region of the zone of the sealinglip device, which is adjacent to the nostrils of a mask user, and whichextends substantially parallel to a transverse line 206 joining theeyebrows. The pivotal position of the mask base body 245 with respect tothe holding portion 234 can be fixed by an arresting device 262. Asufficient relative mobility of the mask base body 245 with respect to abreathing hose connecting portion 248 provided for the connection of arespiratory gas conduit is achieved by a flexible conduit portion 247,as is provided also in the embodiment shown in FIG. 18. In thisembodiment the mask base body is preferably produced integrally with asealing lip device 246 from a elastomer material, preferably siliconerubber. The breathing hose connecting portion 248 in this embodiment isrigidly coupled to the base portion 216 and is made from a hardthermoplastic material.

Mounted to the arm elements 214, 215 there are also forehead pads 249′which are provided to bear against the surface of the forehead of themask user, the forehead pads 249′ being suspended tiltably on trunnionsor projections 262 which are formed integrally with the respective armelement 215, 214. Disposed between the trunnions 262 there is again aneye portion 250 for passing therethrough an end portion of an upper bandarrangement. It is possible for the base portion 216 to be guideddisplaceably on an arm portion 253 a which extends from the holdingportion 234 to the holding foot 253. That makes it possible for thevertical spacing of the forehead support device from the sealing lipdevice 246 also to be variably altered.

FIG. 21 shows a further embodiment of the holding portion 234, as can beused for example in relation to the embodiments shown in FIGS. 19 and20. The holding portion 234 is provided with a coupling structure whichis provided for coupling a mask base body (not shown here) and by meansof which the mask base body can be coupled to the holding portion 234 indifferent coupling positions.

FIG. 22 shows a forehead support device which can be fitted by way of abreathing hose connecting portion 248 onto a connecting part 264 of abreathing mask which is indicated here.

The breathing hose connecting portion 248 is coupled to a base portion216 of the forehead support device by way of a holding foot 253. By wayof an adjusting wheel 222 arranged between the breathing hose connectingportion 48 and the base portion 216 the coupling members 217, 218 areadjustably movable in a direction radially with respect to the axis ofrotation 224 of the adjusting wheel 222. The arm elements 214, 215 aredefinedly pivoted about the axes X1, X2 by suitable positioning of thecoupling members 217, 218.

Mounted to the arm elements 214, 215 are forehead contact pads 249 byway of which the arm elements 214, 215 are supported on the foreheadregion of a mask user. Provided in the region of the forehead pads 249on the arm elements 214, 215 are eye portions 250 through which therespective end portion of an upper belt arrangement can be passed.

FIG. 23 shows a forehead support device which can be used for example inconjunction with the breathing mask 200 shown in FIG. 35. This foreheadsupport device includes a forehead support portion 201 which is madefrom a soft material, in particular elastomer material, and which can beapplied in the forehead region of a mask connector by way of an upperheadband portion of a headband arrangement (see in that respect FIG.37). In this embodiment the forehead support portion 201 includes twotongue portions 202 through which a fixing band portion of the headbandarrangement can be passed. Mounted on the forehead support portion 201is a coupling structure 203 by way of which a conduit connecting element204 is supported at a spacing determined by the geometry of the couplingstructure in front of the lower support surface 205 of the foreheadsupport portion. In this embodiment the conduit connecting element isalso formed from an elastomer material and includes two joining openings206, 207 by way of which the conduit connecting element 204 can besufficiently firmly fitted on to two limb portions 208, 209 of thecoupling structure 203.

The conduit connecting element 204 and the coupling structure 203 can beof such a configuration that the conduit connecting element 204 can besteplessly positioned relative to the forehead support portion 201 inthe direction of the axis X1 indicated here. Further adjustment optionsin respect of the position of the conduit connecting element 204relative to the forehead support portion 201 can be embodied also by theprovision of different possible ways of coupling the coupling structure203 to the forehead support portion 201. In the embodiment illustratedhere it is possible for the longitudinal limbs 208, 210 which here passin pairs through the forehead support portion 201 to be supporteddisplaceably in the forehead support portion 201. The dimensions of thelongitudinal limbs 209, 210 and the through passages provided in theforehead support portion for passing the longitudinal limbs therethroughare preferably established in such a way as to ensure adequatelyfrictional fixing of the coupling structure 203 in the desired relativeposition.

The coupling structure 203 forms a through passage 212 which is of sucha size that a connecting tube portion of a breathing mask (see in thatrespect FIG. 35) can be fitted thereinto. The through passage 212 isfurther of such a dimension that a breathing gas hose can be fittedtherein, on a side remote from the breathing mask, by way of awashing-out valve arrangement.

The spacing between the support surface 205 of the forehead supportportion 201 and the coupling structure 203, which is required accordingto the individual facial structure of the user of the mask, can beadjusted by the provision of various coupling structures 203 or byplastic deformation, for example bending of the coupling structure 203.

FIG. 24 shows a further embodiment of a forehead support device. Thisforehead support device also includes a forehead support portion 201which is made from a sufficiently elastically deformable material,preferably silicone rubber. A conduit passage element 204 a is supporteddisplaceably by way of an adjusting device 214 on the forehead supportportion 201. The conduit passage element 204 a can be of a configurationsimilar to that described hereinbefore with reference to FIG. 23 as aconnecting element by way of which coupling of a connecting portion onthe mask side to a respiratory gas conduit is permitted. As analternative thereto it is also possible for the conduit passage element204 a to be of such a design configuration that it merely embraces arespiratory gas conduit portion and in so doing couples it adjustably inrespect of height to the forehead support portion 201.

In this embodiment the adjusting device 214 includes two adjusting drivedevices 215 by way of which the spacing of the central axis Z of theconduit passage element 204 a with respect to the support surface 205 ofthe forehead support portion 201 is steplessly adjustable. In thisembodiment the adjusting drive devices 215, 216 are provided withinternally threaded sleeves which are manually rotatable by way of aknurling provided on the external periphery thereof. The internallythreaded sleeves are in engagement with screwthread portions (not shown)of adjusting screws 217, 218 so that manual rotation of the respectiveinternally threaded sleeve causes the effective length of a strut formedby the internally threaded sleeve and the adjusting screw in engagementtherewith to be steplessly adjustable. The spacing of the conduitconnecting element 204 a can also be individually adjusted by the userof the mask by varying the effective length of those struts.

Coupling means for coupling the forehead support portion to a headbandarrangement are also provided on the forehead support portion 201. Inthis embodiment those coupling means are afforded by loop elements 220,221.

As can be seen from FIG. 25 the forehead support portion 201 is providedwith support locations 222, 223 in which the two adjusting drive devices215, 216 are respectively anchored on one side. Also provided on theconduit passage element 204 a are support locations 224 in which the endportions of the adjusting screws 217, 218 are sufficiently non-rotatablyanchored.

The arrangement is here such that the operative length of the structurecoupling the conduit passage element 204 a to the respective supportlocations 222, 223 is steplessly variable by actuation of the twoadjusting drive devices 215, 216. By rotation of the internally threadedsleeves which are indicated here and which are knurled on the outsideperiphery (see the arrow symbols in FIG. 24), it is possible to adjustthe position of the conduit passage element 204 a relative to theforehead support portion 201 both in the direction of the axes X, Yindicated here. It is further possible for the conduit passage element204 a also to be pivoted slightly in respect of the longitudinal axis Zthereof.

FIG. 26 is in the form of a detail view showing the coupling structureimplemented in the embodiment of FIGS. 24 and 25 for coupling theforehead support portion 201 to an upper headband. The loop element 220is anchored in the forehead support portion 201 in the region of thatheadband coupling structure. The forehead support portion 201 isprovided with a tongue 227 which is thin at its end and which in theapplication position of the forehead support portion extends between theloop element 220 and the forehead of the user of the mask and in thatsituation cushions a region of the headband which passes around the loopelement 220 and promotes a gentle progressive reduction in the pressurein relation to surface area, caused by the forehead support portion 201.

FIG. 27 shows a preferred embodiment of an adjusting drive device 215 ascan be used in the embodiment of FIGS. 24 and 25. The adjusting drivedevice 215 includes the sleeve 231 which is provided with externalperipheral knurling 230 and which has an internal bore with an internalthread structure. The sleeve 231 includes a pivot portion 232 which ishere of a spherical configuration and can be fitted rotatably into aseat element. The pivot portion 232 can be secured in the seat element233 by way of a spring ring 234 in such a fashion that the pivot portion232 is admittedly rotatable and tiltable through a sufficient angularregion, but it is anchored in the seat element 233 in such a way as tobe secured in the axial direction. A thread portion 235 of the adjustingscrew 217 is in screwthreaded engagement with the sleeve 230 in theassembled condition. Provided on the adjusting screw 217 is a fixinghead 236 which can also be fitted into a seat element 237. The couplingof the fixing head 236 to the seat element 237 is implemented, as adeparture from the manner of coupling the seat element 233 to the pivotportion 232 provided at the sleeve side, in such a way that theadjusting screw 217 is anchored substantially non-rotatably in the seatelement 237.

The adjusting drive device 215 illustrated here makes it possible forthe spacing of the two seat elements 233, 237 to be steplessly adjustedby individual rotation of the sleeve 231.

The conduit passage element 204 a provided in the embodiment of FIGS. 24and 25 can also be of such a configuration that it forms part of therespiratory gas conduit itself. Such a configuration for the conduitpassage element 204 a is shown in FIG. 28. The conduit passage element204 a includes the support portion 238 co-operating with the adjustingdrive devices and a flexible hose conduit portion 239 which is providedin this embodiment. Provided on the hose conduit portion 239 is apush-in sleeve, by way of which a further hose conduit can be rotatablyconnected.

FIG. 29 shows a detail view of a preferred embodiment of the foreheadsupport portion 201 in the region of the forehead support surface 205which bears against the forehead of the user of the mask. Provided inthe forehead support potion 201 are caverns 240 which can provide for aparticularly uniform distribution of surface pressure in the region ofthe contact surface 205.

FIG. 30 is a view in the form of a simplified section showing how theconduit connecting element 204 or also the conduit passage element 204 acan be used for coupling a connecting portion 200 a provided on thebreathing mask 200 to a further respiratory gas conduit member 200 b. Inthis embodiment the respiratory gas conduit member 200 b forms part of awashing-out valve as is described in particular in German patentapplication DE 198 . . . . Provided on the breathing mask 200 are loopportions 200 c, by way of which the breathing mask 200 can be fixed bymeans of a lower headband arrangement in the region of the nose of themask user.

FIG. 31 shows a forehead support device which has substantial points incommon with the embodiment already described hereinbefore with referenceto FIG. 23. The conduit connecting element 204 (also 204 a) is coupledby way of loop elements 243 to the forehead support portion 201.Adjustment of the spacing of the central axis Z of the conduitconnecting element 204 relative to the underside (contact surface 205)of the forehead support portion is achieved in this case in that theloop elements 243 can be fitted into suitably selected bores 244.Depending on which bores 244 are selected for anchoring the loopelements 243 at the forehead support portion, that affords differentspacings of the central axis Z relative to the contact surface 205. Theforehead support portion 201 can be fixed by way of fixing straps 245 toan upper headband arrangement 246. In this embodiment the upper headbandarrangement 246 includes a band portion 247 which extends between thetwo fixing straps 245 under the forehead support portion 201 and in thatcase additionally cushions the forehead support portion against theforehead of the mask user.

FIG. 32 shows a forehead support device for supporting a breathing maskarrangement against the forehead, which also permits stepless adjustmentof the support height. In this embodiment a conduit connecting element204 which can be fitted on to a connecting portion of a breathing maskis pivotably coupled to the coupling structure 203. In this embodimentthe coupling structure 203 is in the form of a bent wire member as isshown by way of example in FIG. 33. The coupling structure 203 inconjunction with an adjusting drive device 215 forms the strut triangleindicated in the diagrammatic view at K1. The strut S1 is in this caseformed by the coupling structure 203, the strut S2 is formed by theconduit connecting element 204 and the strut S3 by the adjusting drive215. A preferred structure of the adjusting drive 215 is illustrated inFIG. 34. The adjusting drive in FIG. 34 includes a screwthreaded spindle250 which is pivotably but non-rotatably coupled to the couplingstructure 203 by way of a pivot head 251 as can be seen in FIG. 32. Thescrewthreaded spindle 250 is in engagement with an internally threadedsleeve 231 which in turn is anchored rotatably by way of a seat element233 in a radially projecting portion 252 of the conduit connectingelement 204. Rotation of the sleeve 231 makes it possible to alter theeffective spacing between the pivot head 251 and the seat element 233and thus to pivot the coupling structure 203 relative to the conduitconnecting element 204. In that way it is possible to implementdifferent relative positions of the lower limbs 203 a relative to abreathing mask connected to the conduit connecting element 204, and thusdifferent forehead spacings.

FIG. 35 shows a breathing mask arrangement comprising a breathing mask200 and a forehead support device coupled thereto. The forehead supportdevice includes an elastically deformable conduit portion 260 which ishere made from an elastomer material. The respiratory gas conduitportion 260 can be adjustably curved by way of an adjusting drive device215. In this embodiment the adjusting drive device includes ascrewthread device having an internally threaded sleeve 231 which is inengagement with a screwthreaded spindle 250. Rotation of the sleeve 230makes it possible to alter the spacing between the points E1 and E2.Upon a change in that spacing the coupling structure 203 which can beseen here is elastically deformed. The deformation characteristic of thecoupling structure 203 is so selected that the cushioning 261 on thecoupling structure 203 always assumes a favourable orientation relativeto the breathing mask 200. The adjusting drive device 215, therespiratory gas conduit portion 260 and a pivotal loop element 262 forma strut triangle which in its basic structure substantially correspondsto the strut triangle described hereinbefore with reference to FIGS.32-34 and the sketch K1 contained therein.

The cushioning 261 is releasably coupled to the coupling structure 203so that the position of the cushioning is adjustably variable in thedirection of the axis Z2 indicated here.

FIG. 36 shows a forehead support device having a conduit passage element204 a which can be fitted on to a breathing mask 200. Provided on thatconduit passage element 204 a is a ball joint trunnion which permitsrotatable and pivotable mounting of a tube sleeve element 270. The tubesleeve element 270 here includes a spherical portion 271 which is ofsuch a configuration that it is carried on the trunnion portion of theconduit passage element 204 a in substantially sealing relationship butsufficiently easily movably thereon. Provided on the tube sleeve element270 is a male screwthread portion 272 which is in threaded engagementwith a coupling structure 203. The coupling structure 203 includes limbportions 203 a which can be coupled to a preferably cushioned upperheadband arrangement 246. By rotation of the tube sleeve element 270about the central axis Z, it is possible, by virtue of the screwthreadengagement between the male threaded portion 272 and the couplingstructure 203, to steplessly vary the spacing between the points E1 andE2. In the region of the points E1, E2 an adjusting loop element 262 ispivotably coupled to the coupling structure 203 and the conduit passageelement 204 respectively. In this embodiment the tube sleeve element 270jointly with the coupling structure 203 forms a strut S1 in the sketchK2 illustrated here. The conduit passage element 204 a, with its portionwhich can be fitted directly on to the breathing mask, forms the strutS2, while in this triangle the pivotal loop element 262 forms the strutS3. By altering the operative length of the strut S1 it is then possiblefor the tube sleeve element 270 and jointly therewith the couplingstructure 203 to be steplessly pivoted about the axis Y indicated here.

The forehead support devices described hereinbefore with reference toFIGS. 35 and 36 make it possible for the support of a breathing mask tobe steplessly matched to the individual facial structure in the regionin which the mask rests on the bridge of the nose of the user. Thecontact pressure in the region of the bridge of the nose can be alteredin particular in the two embodiments described hereinbefore, without inthat respect involving particular changes in the connecting portion atthe respiratory gas conduit side, afforded by the forehead supportdevice.

FIG. 37 shows a headband arrangement which can be used in conjunctionwith the above-described forehead support devices and breathing maskarrangements for the comfortable application of a breathing mask.

The pressure of the breathing mask against the face of the user can beafforded either by applying suitable holding forces by means of theupper headband arrangement 246 and a lower headband arrangement 275 andin particular to transmit the torque required for generating the contactpressure forces in the region of the top lip by way of the loop elements246 illustrated here.

1-20. (cancelled)
 21. A respiratory mask assembly for providingrespiratory therapy to a patient, the respiratory mask assemblycomprising: a frame including headgear connectors, and the frame furtherincluding a conduit carrier portion having an insert opening; a maskreleasably coupled with the frame, the mask including a body portion anda sealing portion, the mask forming a mask internal space pressurizableto a therapeutic pressure above ambient pressure, wherein the bodyportion includes a circular inlet opening structured to receive a flowof air at the therapeutic pressure for breathing by the patient, whereinthe mask includes an inside surface exposed to said therapeutic pressurein use and an outside surface exposed to ambient pressure, and the frameincludes a side wall arranged outside the mask internal space, thesealing portion is constructed and arranged to form a seal with apatient's nose, the sealing portion including an upper lip regionadapted to pass along an upper lip of the patient, wherein the sealingportion comprises an elastomer material and the body portion does notcomprise an elastomer material; a positioning and retaining arrangementstructured and arranged to releasably couple the mask to the frame, thepositioning and retaining arrangement comprising at least onepositioning member provided to the frame, wherein the at least onepositioning member is structured and arranged to extend posteriorly fromthe frame and into the body portion of the mask such that the bodyportion covers the at least one positioning member when the mask and theframe are coupled to one another, and the positioning and retainingarrangement further comprising a mask retainer part provided to the bodyportion of the mask, wherein the mask retainer part is structured andarranged to engage over and behind a frame retainer part of the frame toreleasably retain the mask to the frame; a respiratory gas conduitmember structured to connect to a respiratory gas conduit to deliver theflow of air at the therapeutic pressure to the internal space, and therespiratory gas conduit member having an end portion mounted within theinsert opening of the conduit carrier portion of the frame; headgear tomaintain the respiratory mask assembly in position on a patient's head,the headgear including bands adapted to connect to the headgearconnectors of the frame; and a plurality of outlet openings fordischarge of gas from the mask internal space to ambient atmosphere. 22.The respiratory mask assembly according to claim 21, wherein thepositioning and retaining arrangement further comprises a recessedregion in the frame adapted to receive a protrusion provided to the bodyportion of the mask to facilitate positioning of the mask with respectto the frame, wherein the mask retainer part and the frame retainer partare structured and arranged to at least partly align with one anotheralong a direction of assembly, and the mask retainer part is structuredand arranged to engage over and behind the frame retainer part topositively and releasably interlock the mask and the frame in anassembled position, wherein the respiratory gas conduit member issubstantially circular when viewed in cross-section, further comprisinga connector sleeve rotatably coupled to the respiratory gas conduitmember to allow rotatable movement between the respiratory gas conduitmember and the respiratory gas conduit, wherein the headgear connectorscomprise a pair of slots structured to removably receive respective onesof the bands of the headgear, wherein each of the plurality of outletopenings includes a cross-section that enlarges in an outlet direction,wherein the frame and the carrier portion comprise a one-piecestructure, and wherein the respiratory gas conduit member comprises abend to change a direction of the flow of air therethough.
 23. Therespiratory mask assembly according to claim 22, wherein the maskretainer part and the frame retainer part are structured and arranged toallow deflection into the assembled position.
 24. A respiratory maskassembly for providing respiratory therapy to a patient, the respiratorymask assembly comprising: a frame assembly including a frame and arespiratory gas conduit member provided to the frame, the frameincluding a pair of upper headgear connectors and a pair of lowerheadgear connectors, and the frame further including a conduit carrierportion having an insert opening, the respiratory gas conduit memberstructured to connect to a respiratory gas conduit, and the respiratorygas conduit member is mounted within the insert opening of the conduitcarrier portion of the frame; a mask releasably coupled with the frameassembly, the mask including a body portion and a sealing portion, thebody portion forming a mask internal space pressurizable to atherapeutic pressure above ambient pressure, and the body portionincluding a circular inlet opening structured to receive a flow of airat the therapeutic pressure from the respiratory gas conduit member forbreathing by the patient, wherein the body portion includes an insidesurface exposed to said therapeutic pressure in use and an outsidesurface exposed to ambient pressure, and the frame includes a wallarranged outside the mask internal space and arranged to cover a portionof the mask when the mask and the frame assembly are coupled to oneanother, wherein the body portion includes a plurality of outletopenings for discharge of gas from the mask internal space to ambientatmosphere, and the frame includes a portion that is adjacent and passesbelow the plurality of outlet openings when the mask and the frameassembly are coupled to one another, the sealing portion is constructedand arranged to form a seal with a patient's nose and mouth, wherein thesealing portion comprises an elastomer material and the body portiondoes not comprise an elastomer material; a positioning and retainingarrangement structured and arranged to releasably couple the mask to theframe assembly, the positioning and retaining arrangement comprising arecessed region in the frame adapted to receive a protrusion provided tothe body portion of the mask to facilitate positioning of the mask withrespect to the frame assembly, and the positioning and retainingarrangement further comprising a frame retainer part provided to therespiratory gas conduit member and a mask retainer part provided to thebody portion of the mask, wherein the frame retainer part projectsbeyond the conduit carrier portion of the frame, and when the mask andthe frame assembly are coupled to one another, the frame retainer partextends through the circular inlet opening of the body portion and themask retainer part engages over and behind the frame retainer part toreleasably retain the mask to the frame assembly, and wherein the frameretainer part comprises a bead adjacent a distal end of the respiratorygas conduit member and the mask retainer part comprises an internalsurface of the body portion of the mask arranged to engage behind thebead when the mask and the frame assembly are coupled to one another;and headgear to maintain the respiratory mask assembly in position on apatient's head, the headgear including upper bands adapted to connect tothe upper headgear connectors of the frame and lower bands adapted toconnect to the lower headgear connectors of the frame, and the upperbands adapted to be routed over respective ones of a patient's ears andthe lower bands adapted to be routed under respective ones of thepatient's ears.
 25. The respiratory mask assembly according to claim 24,wherein the respiratory gas conduit member is substantially circularwhen viewed in cross-section, wherein the upper headgear connectorscomprise a pair of slots structured to removably receive respective onesof the upper bands of the headgear and the lower headgear connectorscomprise a pair of slots structured to removably receive respective onesof the lower bands of the headgear, wherein each of the plurality ofoutlet openings includes a cross-section that enlarges along its length,wherein the frame and the carrier portion comprise a one-piecestructure, and wherein the respiratory gas conduit member comprises abend to change a direction of the flow of air therethough.
 26. Therespiratory mask assembly according to claim 25, wherein the maskretainer part and the frame retainer part are structured and arranged toallow deflection into an assembled position.
 27. A respiratory maskassembly for providing respiratory therapy to a patient, the respiratorymask assembly comprising: a frame including a main body and a foreheadsupport extending from the main body, the forehead support including apair of upper headgear connectors and the main body including a pair oflower headgear connectors; a mask releasably coupled with the frame, themask including a body portion and a sealing portion, the body portionforming a mask internal space pressurizable to a therapeutic pressureabove ambient pressure, and the body portion including a circular inletopening structured to receive a flow of air at the therapeutic pressurefor breathing by the patient, wherein the body portion includes aninside surface exposed to said therapeutic pressure in use and anoutside surface exposed to ambient pressure, and the main body of theframe includes a side wall arranged along the outside surface of thebody portion so that the side wall is outside the mask internal space,the sealing portion is constructed and arranged to form a seal with apatient's nose and mouth, the sealing portion including a hole thereinadapted to receive the patient's nose and mouth such that the flow ofair at the therapeutic pressure is delivered to the patent's nose andmouth, wherein the sealing portion comprises an elastomer material andthe body portion does not comprise an elastomer material; a positioningand retaining arrangement structured and arranged to releasably couplethe body portion of the mask to the main body of the frame in asubstantially fixed, substantially non-adjustable position to resistadjustable movement between the body portion of the mask and the mainbody of the frame, the positioning and retaining arrangement comprisinga pair of positioning members provided to the frame, wherein the pair ofpositioning members are structured and arranged to protrude from themain body of the frame and into respective pocket portions provided inthe body portion of the mask when the mask and the frame are coupled toone another, and the positioning and retaining arrangement furthercomprising a mask retainer part provided to the body portion of themask, wherein the mask retainer part is structured and arranged toengage behind a frame retainer part of the frame to releasably retainthe mask to the frame; a respiratory gas conduit member structured toconnect to a respiratory gas conduit to deliver the flow of air at thetherapeutic pressure to the internal space, and the respiratory gasconduit member is configured to communicate with the mask through thecircular inlet opening of the body portion; and headgear to maintain therespiratory mask assembly in position on a patient's head, the headgearincluding upper bands adapted to connect to the upper headgearconnectors of the frame and lower bands adapted to connect to the lowerheadgear connectors of the frame, and the upper bands adapted to berouted over respective ones of a patient's ears and the lower bandsadapted to be routed under respective ones of the patient's ears. 28.The respiratory mask assembly according to claim 27, wherein the bodyportion includes a plurality of outlet openings for discharge of gasfrom the mask internal space to ambient atmosphere, wherein the mainbody of the frame includes a closed ring or closed loop configurationstructured and arranged to wrap around the mask when the mask and theframe are coupled to one another, further comprising a connector sleeverotatably coupled to the respiratory gas conduit member to allowrotatable movement between the respiratory gas conduit member and therespiratory gas conduit, wherein the upper headgear connectors comprisea pair of slots structured to removably receive respective ones of theupper bands of the headgear, wherein the frame has a front side and arear side, and the frame includes an opening through which at least aportion of the body portion is exposed towards the front side of theframe, and the plurality of outlet openings are exposed towards thefront side of the frame, and wherein the respiratory gas conduit membercomprises a bend to change a direction of the flow of air therethough.29. The respiratory mask assembly according to claim 28, wherein themask retainer part and the frame retainer part are structured andarranged to allow deflection into an assembled position.
 30. Arespiratory mask assembly for providing respiratory therapy to apatient, the respiratory mask assembly comprising: a frame including apair of upper headgear connectors and a pair of lower headgearconnectors; a mask releasably coupled with the frame, the mask includinga body portion and a sealing portion, the body portion forming a maskinternal space pressurizable to a therapeutic pressure above ambientpressure, and the body portion including a circular inlet openingstructured to receive a flow of air at the therapeutic pressure forbreathing by the patient, wherein the body portion includes an insidesurface exposed to said therapeutic pressure in use and an outsidesurface exposed to ambient pressure, and the frame includes a side wallarranged along the outside surface of the body portion so that the sidewall is outside the mask internal space, the sealing portion isconstructed and arranged to form a seal with a patient's nose and mouth,the sealing portion including a hole therein adapted to receive thepatient's nose and mouth such that the flow of air at the therapeuticpressure is delivered to the patent's nose and mouth, wherein thesealing portion comprises an elastomer material and the body portiondoes not comprise an elastomer material; a positioning and retainingarrangement structured and arranged to releasably couple the mask to theframe in a substantially fixed, substantially non-adjustable position toresist adjustable movement between the mask and the frame, thepositioning and retaining arrangement comprising a pair of positioningmembers provided to the frame, wherein the pair of positioning membersare structured and arranged to protrude from the frame and intorespective pocket portions provided in the body portion of the mask whenthe mask and the frame are coupled to one another, and the positioningand retaining arrangement further comprising a mask retainer partprovided to the body portion of the mask, wherein the mask retainer partis structured and arranged to engage behind a frame retainer part of theframe to releasably retain the mask to the frame; a respiratory gasconduit member structured to connect to a respiratory gas conduit todeliver the flow of air at the therapeutic pressure to the internalspace, and the respiratory gas conduit member is configured tocommunicate with the mask through the circular inlet opening of the bodyportion; and headgear to maintain the respiratory mask assembly inposition on a patient's head, the headgear including upper bands adaptedto connect to the upper headgear connectors of the frame and lower bandsadapted to connect to the lower headgear connectors of the frame, andthe upper bands adapted to be routed over respective ones of a patient'sears and the lower bands adapted to be routed under respective ones ofthe patient's ears.
 31. The respiratory mask assembly according to claim30, wherein the body portion includes a plurality of outlet openings fordischarge of gas from the mask internal space to ambient atmosphere,wherein the frame includes a closed ring or closed loop configurationstructured and arranged to wrap around the mask when the mask and theframe are coupled to one another, further comprising a connector sleeverotatably coupled to the respiratory gas conduit member to allowrotatable movement between the respiratory gas conduit member and therespiratory gas conduit, wherein the upper headgear connectors comprisea pair of slots structured to removably receive respective ones of theupper bands of the headgear, wherein the frame has a front side and arear side, and the frame includes an opening through which at least aportion of the body portion is exposed towards the front side of theframe, and the plurality of outlet openings are exposed towards thefront side of the frame, and wherein the respiratory gas conduit membercomprises a bend to change a direction of the flow of air therethough.32. The respiratory mask assembly according to claim 31, wherein themask retainer part and the frame retainer part are structured andarranged to allow deflection into an assembled position.